Training in Clinical Trials for Subjects with Low Vision

低视力受试者临床试验培训

• 批准号: 7915355
• 负责人: AVA K BITTNER
• 金额: $ 17.2万
• 依托单位: JOHNS HOPKINS UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-09-01 至 2012-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7915355
• 关键词: Address; Affect; Anxiety; Behavioral; Blindness; Characteristics; Chronic; Chronic Disease; Chronic stress; Clinical; Clinical Research; Clinical Trials; Cognitive; Complementary and alternative medicine; Conduct Clinical Trials; Data; Data Analyses; Devices; Distress; Doctor of Philosophy; Emotional; Environmental Risk Factor; Evaluation; Exercise; Eye; Fatigue; Focus Groups; Fundus photography; Future; Goals; Home environment; Hydrocortisone; Individual; Instruction; Intervention; Laboratories; Lead; Life Experience; Light; Measurement; Measures; Mental Depression; Mentors; Methodology; Mind-Body Intervention; Moods; Motivation; Nature; Night Blindness; Ophthalmoscopy; Outcome Measure; Patients; Perception; Phenotype; Physical activity; Play; Progress Reports; Psychological Factors; Psychophysiology; Psychosocial Stress; Quality of life; Questionnaires; Randomized; Recovery; Reporting; Research; Research Design; Research Personnel; Research Project Grants; Resources; Retinitis Pigmentosa; Role; Salivary; Scientist; Self-Administered; Series; Sleep; Sleep disturbances; Source; Stress; Test Result; Testing; Time; Training; Training Programs; Variant; Vision; Vision Tests; Visual; Visual Acuity; Visual Fields; Visual impairment; Weather; Work; base; body-mind; career; depressive symptoms; diaries; disabling disease; experience; group intervention; impression; improved; legally blind; meetings; mindfulness-based stress reduction; negative mood; post intervention; programs; psychologic; statistics

DESCRIPTION (provided by applicant): The primary aim of this career training proposal is to train Ava Kiser, O.D. to become a successful, independent clinician-scientist, capable of performing high-quality clinical research in low vision. This goal will be accomplished through a mentored research project and didactic coursework leading to a PhD degree in clinical investigation. Two types of mentors will be involved in the training plan, related to 1) psychological evaluations and mindfulness-based stress reduction interventions for those with chronic disease; and 2) clinical trials, including data analysis statistics, study design and methodology. Numerous institutional resources will also play a supporting role during this training program. The candidate's research goals include the conduct of clinical trials in low vision, potentially involving Complementary and Alternative Medicine (CAM) or other interventions in visually impaired patients.. Negative psychological states such as distress, anxiety and depression are common in retinitis pigmentosa (RP) due to the chronic, slowly progressive nature of this disabling disease. Psychophysical vision measures are more variable in legally blind RP subjects than in normally sighted individuals, and RP patients indicate that variations in vision are often related to stress or fatigue. Short term research aims are to determine whether within and between day fluctuations in visual acuity, contrast sensitivity and visual field among RP patients are associated with perceived stress, sleepiness or negative mood states. This will be accomplished with at home PC-based questionnaires and vision tests, self-administered by the subjects at various times of the day and days of the week. We will also assess the impact of light exposure, sleep, and lab-induced pychosocial stress upon vision tests, to establish a profile of the characteristics of the RP subjects with the most variable vision. The candidate's training will include a small clinical trial to attempt to alleviate these factors in RP patients with a mind-body, cognitive-behavioral stress reduction intervention versus a control eye exercise program. Sources for the variability of vision measurements during future treatment clinical trials need to be identified and addressed before results can be properly assessed. This research may indicate the value of CAM-related interventions, and thus potentially improve the reliability of vision tests as outcome measures during future clinical trials and the quality of life for RP patients.

描述(由申请者提供)：本职业培训计划的主要目标是培养Ava Kiser，O.D.成为一名成功的、独立的临床科学家，能够在低视力下进行高质量的临床研究。这一目标将通过一个有指导的研究项目和教学课程来实现，从而获得临床研究的博士学位。培训计划将涉及两种类型的导师，涉及1)针对慢性病患者的心理评估和正念减压干预；2)临床试验，包括数据分析统计、研究设计和方法。众多机构资源也将在此次培训中发挥辅助作用。候选人的研究目标包括进行低视力的临床试验，可能涉及补充和替代医学(CAM)或其他针对视障患者的干预措施。由于视网膜色素变性(RP)是一种慢性的、进展缓慢的疾病，因此这种疾病的负面心理状态，如痛苦、焦虑和抑郁是常见的。心理物理视力测量在合法失明的RP受试者中比在正常视力的个体中更具变异性，并且RP患者表明视力的变化通常与压力或疲劳有关。短期研究的目的是确定RP患者的视力、对比敏感度和视野的日内和日间波动是否与感受到的压力、嗜睡或消极情绪状态有关。这将通过在家中基于PC的问卷和视力测试来完成，这些问卷和视力测试由受试者在一天中的不同时间和一周中的几天自行进行。我们还将评估光线暴露、睡眠和实验室诱导的心理应激对视力测试的影响，以建立视力变化最大的RP受试者的特征。候选人的训练将包括一项小型临床试验，试图通过心理-身体、认知-行为减压干预和对照眼操计划来缓解RP患者的这些因素。在对结果进行适当评估之前，需要确定和解决未来治疗临床试验期间视力测量变异性的来源。这项研究可能表明与CAM相关的干预措施的价值，从而潜在地提高视力测试作为未来临床试验和RP患者生活质量结果指标的可靠性。